http://www.amgennews.com/index.php en pmannle@amgen.com Copyright 2010 2010-02-19T23:24:01+00:00 http://www.amgennews.com/index.php/2008NewsService/fda_classifies_proliatm_denosumab_complete_response_submission_and_targets_/ http://www.amgennews.com/index.php/2008NewsService/fda_classifies_proliatm_denosumab_complete_response_submission_and_targets_/#When:23:24:01Z THOUSAND OAKS, Calif., Feb 19, 2010 /PRNewswire via COMTEX/—Amgen Inc. (Nasdaq: AMGN) today announced that the U.S. Food and Drug Administration (FDA) has evaluated the content of the Company’s Complete Response submission for Prolia(TM) (denosumab) in the treatment of postmenopausal osteoporosis and classified it as a Class 2 resubmission. With the Class 2 designation, the FDA set a corresponding Prescription Drug User Fee Act (PDUFA) action date of July 25, 2010. Press Releases 2010-02-19T23:24:01+00:00 http://www.amgennews.com/index.php/2008NewsService/amgen_and_centocor_ortho_biotech_products_finalize_esa_risk_evaluation_and_/ http://www.amgennews.com/index.php/2008NewsService/amgen_and_centocor_ortho_biotech_products_finalize_esa_risk_evaluation_and_/#When:23:32:01Z THOUSAND OAKS, Calif., Feb 16, 2010 /PRNewswire via COMTEX/—Amgen Inc.  (Nasdaq: AMGN) and Centocor Ortho Biotech Products, L.P., today announced that the U.S. Food and Drug Administration (FDA) has approved the Risk Evaluation and Mitigation Strategy (REMS) for erythropoiesis-stimulating agents (ESAs), which include Aranesp(R) (darbepoetin alfa), EPOGEN(R) (Epoetin alfa) and PROCRIT(R) (Epoetin alfa). The FDA has determined that a REMS is necessary for ESAs to ensure the benefits of these drugs outweigh the risks of shortened overall survival and/or increased tumor progression or recurrence as identified in clinical studies in patients with breast, non-small cell lung, head and neck, lymphoid and cervical cancers. Press Releases 2010-02-16T23:32:01+00:00 http://www.amgennews.com/index.php/2008NewsService/denosumab_demonstrated_superiority_over_zometar_in_pivotal_phase_3_head_to_/ http://www.amgennews.com/index.php/2008NewsService/denosumab_demonstrated_superiority_over_zometar_in_pivotal_phase_3_head_to_/#When:19:26:00Z THOUSAND OAKS, Calif., Feb 08, 2010 /PRNewswire via COMTEX/—Amgen (Nasdaq: AMGN) today announced that a pivotal, Phase 3, head-to-head trial evaluating denosumab versus Zometa(R) (zoledronic acid) in the treatment of bone metastases in 1,901 men with advanced prostate cancer met its primary and secondary endpoints. Denosumab demonstrated superiority over Zometa for both delaying the time to the first on-study skeletal related event (SRE) (fracture, radiation to bone, surgery to bone or spinal cord compression) (hazard ratio 0.82, 95 percent CI: 0.71, 0.95), and reducing the rate of multiple SREs (hazard ratio 0.82, 95 percent CI: 0.71, 0.94). Both results were statistically significant. Press Releases 2010-02-08T19:26:00+00:00 http://www.amgennews.com/index.php/2008NewsService/amgens_fourth_quarter_2009_adjusted_earnings_per_share_decreased_1_percent_/ http://www.amgennews.com/index.php/2008NewsService/amgens_fourth_quarter_2009_adjusted_earnings_per_share_decreased_1_percent_/#When:20:23:00Z THOUSAND OAKS, Calif., Jan 25, 2010 /PRNewswire via COMTEX/—Amgen (Nasdaq: AMGN) reported adjusted earnings per share (EPS) of $1.05 for the fourth quarter of 2009, a decrease of 1 percent compared to $1.06 for the fourth quarter of 2008. Adjusted net income decreased 5 percent to $1,065 million in the fourth quarter of 2009 compared to $1,124 million in the fourth quarter of 2008. Press Releases 2010-01-25T20:23:00+00:00 http://www.amgennews.com/index.php/2008NewsService/amgen_presents_complete_results_from_two_pivotal_phase_3_studies_of_vectibi/ http://www.amgennews.com/index.php/2008NewsService/amgen_presents_complete_results_from_two_pivotal_phase_3_studies_of_vectibi/#When:20:32:00Z THOUSAND OAKS, Calif., Jan 21, 2010 /PRNewswire via COMTEX/ —Amgen (Nasdaq: AMGN) today announced that detailed results from two pivotal Phase 3 studies evaluating Vectibix(R) (panitumumab) in combination with chemotherapy for the first and second-line treatment of metastatic colorectal cancer (mCRC) (the PRIME ‘203’ and ‘181’ trials, respectively) will be presented at the 2010 American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium in Orlando, Florida from Jan. 22-24, 2010. Press Releases 2010-01-21T20:32:00+00:00 http://www.amgennews.com/index.php/2008NewsService/amgen_announces_webcast_of_2009_fourth_quarter_and_full_year_financial_resu/ http://www.amgennews.com/index.php/2008NewsService/amgen_announces_webcast_of_2009_fourth_quarter_and_full_year_financial_resu/#When:20:38:00Z THOUSAND OAKS, Calif., Jan 20, 2010 /PRNewswire via COMTEX/ —Amgen (Nasdaq: AMGN) today announced that it plans to report its fourth quarter and full year financial results on Monday, Jan. 25, 2010 after the close of the financial markets. The announcement will be followed by a conference call with the investment community at 2:00 p.m. Pacific Time. Participating in the call from Amgen will be Kevin Sharer, chairman and chief executive officer, and other members of Amgen’s senior management team. Press Releases 2010-01-20T20:38:00+00:00 http://www.amgennews.com/index.php/2008NewsService/amgen_donates_2_million_establishes_earthquake_relief_program/ http://www.amgennews.com/index.php/2008NewsService/amgen_donates_2_million_establishes_earthquake_relief_program/#When:20:40:00Z THOUSAND OAKS, Calif., Jan 14, 2010 /PRNewswire via COMTEX/—Amgen (Nasdaq:  AMGN) today announced that the company will donate $2 million to Haiti relief efforts. Amgen staff are being encouraged to be generous and that effort should also generate meaningful additional support. Press Releases 2010-01-14T20:40:00+00:00 http://www.amgennews.com/index.php/2008NewsService/amgen_receives_chmp_positive_opinion_for_proliatm_denosumab_in_the_european/ http://www.amgennews.com/index.php/2008NewsService/amgen_receives_chmp_positive_opinion_for_proliatm_denosumab_in_the_european/#When:04:20:01Z THOUSAND OAKS, Calif. – Dec 18, 2009 – Amgen Inc. (Nasdaq: AMGN) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has announced a positive opinion for the marketing authorization of Prolia((TM)) (denosumab) for the treatment of osteoporosis in postmenopausal women at increased risk of fractures, and for the treatment of bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures. If approved by the European Commission, Amgen would receive marketing authorization for Prolia in all European Union (EU) Member States. Press Releases 2009-12-18T04:20:01+00:00 http://www.amgennews.com/index.php/2008NewsService/new_amgen_scholars_web_site_launches_to_build_a_global_network_for_future_s/ http://www.amgennews.com/index.php/2008NewsService/new_amgen_scholars_web_site_launches_to_build_a_global_network_for_future_s/#When:19:21:00Z THOUSAND OAKS, Calif. (Dec. 3, 2009) – Each year, hundreds of undergraduate students from across the United States (U.S.) and Europe participate in the Amgen Scholars Program to gain hands-on laboratory experience under renowned faculty members at the world’s leading universities.  Now, the Amgen Scholars – past, present and future – will have exclusive access to the online Amgen Scholars Community at www.amgenscholars.com. Press Releases 2009-12-03T19:21:00+00:00 http://www.amgennews.com/index.php/2008NewsService/amgen_highlights_data_to_be_presented_at_ash/ http://www.amgennews.com/index.php/2008NewsService/amgen_highlights_data_to_be_presented_at_ash/#When:19:14:00Z THOUSAND OAKS, Calif., Nov. 30 /PRNewswire-FirstCall/—Amgen Inc. (Nasdaq: AMGN) today announced that it will present updated long-term safety and efficacy data for Nplate?? (romiplostim) in adult chronic immune (idiopathic) thrombocytopenic purpura (ITP). Additionally, Amgen will present the first Nplate study in a pediatric setting as well as in patients with myelodysplastic syndromes (MDS) at the 2009 American Society of Hematology (ASH) Annual Meeting and Exposition (Dec. 5 - 8, 2009). Press Releases 2009-11-30T19:14:00+00:00